Method and apparatus for dispensing a composition

ABSTRACT

A pharmaceutical dispenser including a tube having an open end and a space filled with a composition, and an applicator including a first end removably coupled to the open end of the tube and a longitudinal portion with at least one aperture is described. The dispenser can also include a removable cover extending longitudinally and having a bore surrounding the longitudinal portion of the applicator. The composition may be an anal medication. A single dosage unit of the composition is usually contained in the tube, and the tube, applicator, and cover are disposable after use. Methods of using the dispenser include squeezing the tube, allowing the composition to exit the aperture of the applicator, and applying the composition to a target area.

TECHNICAL FIELD

The present invention relates to dispensers and, more particularly, to acontainer and applicator for dispensing a composition such as apharmaceutical composition.

BACKGROUND

Containers used to hold compositions can perform various functionsbeyond that of simply housing the composition. For example, containerscan be sized to dispense a specified dosage of the composition, as wellas to assist in the application of the composition to a target area.

For example, in the context of medications used to treat anal ailmentssuch as hemorrhoids, anal fissures, pruritis ani and similar conditionsof the anal area (collectively, “heinorrhoids”), current packaging andapplication methods of compositions have generally been large,re-useable, bulky tubes accompanied by screw-on, multiple useapplicators. See, for example, the applicator disclosed in U.S. Pat. No.4,808,166 to Davidov. Treatments employing this historic methodologyhave generally resulted in unpleasant and inconvenient incidents forpatients and potentially ineffective treatments. The unpleasantincidents include leaky and messy tubes containing the pharmaceuticalcompound and leaky and dirty applicators resulting from repeated use.Another inconvenience arises from the absolute necessity, for sanitarypurposes, of thoroughly cleaning and drying a multiple use applicatorafter each treatment. Further, since the pharmaceutical is beingdispensed from a large, multiple use tube, the potential for a patientto under or over-medicate his or herself exists because dosing amountscannot be ascertained accurately.

It is therefore desirable to provide a dispenser and method fordispensing a composition that are sanitary, convenient to use, andprovide accurate dosage amounts.

SUMMARY

The present invention relates to dispensers and, more particularly, to acontainer and applicator for dispensing a composition such as apharmaceutical composition.

According to one aspect of the invention, a pharmaceutical dispenserincludes a tube including an open end and defining a space filled with acomposition, and an applicator including a first end removably coupledto the open end of the tube and a longitudinal portion defining at leastone aperture. The dispenser also includes a removable cover extendinglongitudinally and defining a bore surrounding the longitudinal portionof the applicator.

According to another aspect of the invention, a kit for application ofanal medication includes a tube including an open end and defining aspace filled with a composition; an applicator including a first endconfigured to mate with the open end of the tube and a longitudinalportion defining at least one aperture; and a sealed package defining aninterior sized to accommodate the tube and the applicator.

According to yet another aspect of the invention, a method fordispensing a pharmaceutical includes: providing a tube including an openend and defining a space filled with a composition; removing a cap fromthe open end of the tube; mating a first end of an applicator with theopen end of the tube; and dispensing the composition through an aperturedefined by a longitudinal portion of the applicator onto a target area.

The above summary is not intended to describe each disclosed embodimentor every implementation of the present invention. The figures and thedetailed description which follow more particularly exemplify theseembodiments.

DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a top view of an example pharmaceutical dispenser made inaccordance with the present invention;

FIG. 1A is a top view of the dispenser of FIG. 1 with the cover removed;

FIG. 2 is a side view of an example container including a cap made inaccordance with the present invention;

FIG. 3 is a side view of the container of FIG. 2 with the cap removed;

FIG. 4 is a perspective view of an example applicator made in accordancewith the present invention;

FIG. 5 is a cross-sectional view taken along line 5-5 of the applicatorof FIG. 4;

FIG. 6 is a perspective view of an example cover made in accordance withthe present invention;

FIG. 7 is a cross-sectional view taken along line 7-7 of the cover ofFIG. 6;

FIG. 8 is a bottom, partial-cutaway view of an example package enclosinga container, an applicator, and a cover in accordance with the presentinvention;

FIG. 9 is a side view of the package of FIG. 8; and

FIG. 10 is an end view of the package of FIG. 8.

While the disclosed subject matter is amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the invention tothe particular embodiments described. On the contrary, the intention isto cover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

The present invention relates to dispensers and, more particularly, to acontainer and applicator for dispensing a composition such as apharmaceutical composition.

Generally, the present invention is directed to a pharmaceuticaldispenser including a container and an applicator. The containerincludes an interior for holding a composition, and an open end. Theapplicator includes a first end coupled to the open end of thecontainer, and at least one aperture. The composition is dispensed outof the container, through the applicator, and out the aperture to atarget area.

In the examples shown, the composition may be any composition used totreat anal ailments such as, for example, hemorrhoids, anal fissures,pruritis ani and similar conditions of the anal area (collectively,“hemorrhoids”). In the embodiment shown, the composition used isAnaMantle® HC available from Kenwood Therapeutics, a division of BradleyPharmaceuticals, Inc. of Fairfield, N.J. AnaMantle® HC containslidocaine HCl 3% and hydrocortisone acetate 0.5% microdispersed in anAcidMantle vehicle. Lidocaine is chemically designated as acetamide,2-(diethylamino)-N-(2,6-dimethylphenyl). Hydrocortisone acetate has achemical name pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-(11β)-. Other anal medicationsmay also be selected as the composition, as desired. The examplecontainers described herein hold a single dosage unit of the compositionto be used for the relief of symptoms common to hemorrhoids, includingswelling and inflammation of the anal area and rectal discomfort anditching.

Referring now to FIGS. 1 and 1A, an example pharmaceutical dispenser 100is shown. The dispenser 100 includes a container, in the illustratedembodiment a tube 110, as well as an applicator 120 and a cover 130. Afirst end 122 of the applicator 120 is coupled to the tube 110, and thecover 130 is coupled to and surrounds a portion of the applicator 120.

Referring now to FIGS. 2 and 3, the example tube 110 is shown in moredetail. The tube 110 includes an interior space 210 that is filled withthe composition. A first end 220 of the tube 110 is sealed, while asecond end 230 is open. The tube 110 is shown with a cap 240 screwedonto the open end 230 of the tube 110 in FIG. 2, and with the cap 240removed in FIG. 3. With the cap 240 secured onto the open end 230 of thetube 110, the composition is maintained within the space 210 of the tube110. When the cap 240 is removed, the tube 110 can be squeezed todispense the composition out of the open end 230. In the example shown,the space 210 of the tube 110 is sized to hold a single dosage unit ofthe composition. Other dosage amounts may also be used. The example tube110 is approximately 5.5-6.5 cm in length, although other dimensions forthe tube may be used.

Referring now to FIGS. 4 and 5, the example applicator 120 is shown inmore detail. The first end 122 of the applicator 120 is open andincludes a threaded bore 510 sized to screw onto the open end 230 of thetube 110 (see FIGS. 1 and 1A). An outer surface 420 of the first end 122is ribbed to assist a user in screwing the applicator 120 onto the tube110. The applicator 120 also includes a longitudinal portion 430extending from the first end 122 to a second end 432. The longitudinalportion 430 is tapered as it extends from the first end 122 to thesecond end 432. An aperture 434 is defined at the second end 432.Further, additional apertures 436 may be positioned about thelongitudinal portion 430. In the embodiment shown, the eight apertures436 are positioned in a staggered-pair arrangement about thelongitudinal portion 430. An internal cavity 540 formed within theapplicator 120 (see FIG. 5) is fluidly coupled to the threaded bore 510,and the apertures 434 and 436 extend through the longitudinal portion430 into the cavity 540. A circumferential rib 450 is positioned aboutthe outer circumference of the longitudinal portion 430 to hold thecover 130 in position on the applicator 120, as described further below.In the example shown, the applicator 120 is made of low densitypolyethylene and is approximately 4.5-5.0 cm in length. Other materialsand lengths may also be used.

With the applicator 120 screwed onto the tube 110 and the cover 130 isremoved (see FIG. 1A), the tube 110 can be squeezed, causing thecomposition to exit the open end 230 of the tube 110 and enter the bore510. As the bore 510 is filled with the composition, the compositionmoves into the cavity 540 and is eventually forced out of the apertures434 and 436 and onto a target area. As described further below, theapplicator 120 is advantageously shaped for applying the pharmaceuticalto the target area.

Referring now to FIGS. 6 and 7, the example cover 130 is shown in moredetail. The cover 130 includes an open end 610 and cavity 720 sized tofit over and accept a portion of the longitudinal portion 430 of theapplicator 120. (see FIG. 1). An opposite end 612 is closed.Circumferential ribs 730, 732, and 734 are fonmed on the interiorsurface of the cavity 720. The rib 734 is positioned to pass over therib 450 of the applicator 120 as the cover 130 is slid over theapplicator and thereby hold the cover 130 onto the applicator 120 by aninterference fit. An optional protrusion 740 may extend from the end 612to engage and partially extend through the aperture 434 fonned in thesecond end 432 of the applicator 120 to further hold the cover 130 inplace. In the example shown, the cover 130 is made of low densitypolyethylene and is approximately 3.5-4.0 cm in length. Other materialsand lengths may also be used.

The cover 130 functions to protect and maintain the applicator 120 untiluse. In addition, the cover 130 (as well as the protrusion 740, ifincluded) at least partially plugs the apertures 434 and 436 of theapplicator 120 to reduce an amount of the composition that escapes theapplicator 120 when the cover 130 is in place. In alternativeembodiments, the cover 130 need not be used.

Referring now to FIGS. 8-10, an example package 810 is shown to hold thetube 110, applicator 120, and cover 130 for distribution. The packageincludes a base 820 (approximately 86.25 mm long and 61.00 mm wide inthe embodiment shown) and an upper plastic bubble 930 surrounding thecomponents of the dispenser 100. In the example shown, the plasticbubble 930 rises approximately 17.50 mm above the base 820 and is madeof 12-mil polyvinyl chloride plastic laminate. Also included in theexample shown is a 1-mil child resistant aluminum foil that seals thepackage 810. The seal includes perforations 840 located at each cornerof the base 820 to allow the seal to be peeled from the bubble 930 toprovide access to the dispenser 100. The example package 810 can beobtained from Blispak, Inc. of Whippany, N.J., control number 2370.Another configuration for a package that may be used to house thedispenser is disclosed in U.S. Pat. No. 3,912,082 to Gemer et al., whichis hereby incorporated by reference. Other configurations for packagesused to hold the dispenser 100 may also be used.

An example method for using the dispenser 100 is a follows. First, thecomponents of the dispenser 100 are removed from the package 810. Next,the cap 240 is removed from the tube 110, and the applicator 120 (withthe cover 130 in place) is screwed firmly onto the open end 230 of thetube and tightened. While holding the tube 110, the cover 130 is thenremoved from the applicator 120, and the tube is squeezed to fill theapplicator 120 until a small amount of the composition exits theapertures 434 and 436 formed in the applicator and lubricates the outersurface of the applicator 120 with the composition. Next, in the contextof anal medication, the applicator is gently inserted into the analarea, and the tube 110 is squeezed as the applicator is moved around thetarget area. Once the application of the composition is completed, thedispenser 100, including the tube 110, the applicator 120, and the cover130, is configured to be disposable.

There are many advantages to the dispenser 100 made in accordance withthe present invention. For example, each tube can be a single-use tubethat is filled with a precisely-measured single dosage unit of thecomposition to reduce errors associated with incorrect dosageapplications. Further, because the dispenser 100 contains a singledosage unit and is disposable, it can be used for a prescribed treatmentand thereafter discarded in its entirety by the user, thereby increasingsanitation. The tube is sealed, sanitary and has an easy-to-usescrew-off top. The shape of the applicator, including the long, taperedlongitudinal portion and smooth, closed sides allows for easyapplication of the composition. Further, because of the package anddispenser size, it is easily portable and can easily be carried in auser's pocket, small purse or small bag.

Although the composition has been described herein as an analmedication, it should be understood that other substances could also beused as the composition. For example, any other composition that is in aform such that it can be placed in the container and delivered by theapplicator to a target area may also be used, such as otherphannaceutical agents, cosmetics, etc.

The present invention should not be considered limited to the particularexamples described above, but rather should be understood to cover allaspects of the disclosed subject matter as fairly set out in theattached claims. For example, although the illustrated embodimentsdescribe a threaded connection between the container and the applicator,other methods of connecting the two components, such as a snap-fitconnection, may also be used. Various other modifications, equivalentprocesses, as well as numerous structures to which the present inventionmay be applicable will be readily apparent to those of skill in the artto which the present invention is directed upon review of the instantspecification.

1. A disposable single-use pharmaceutical dispenser for anorectaltopical application, comprising: a reservoir portion defining a space,the reservoir portion being formed of a material deformable bysqueezing, the reservoir portion has a length of less than approximately5.5 to 6.5 cm; the single dosage amount of a pharmaceutical compositioncomprising lidocaine and hydrocortisone acetate, the pharmaceuticalcomposition substantially filling the space of the reservoir portion,the single dosage amount of the pharmaceutical composition formulatedfor topical non-systemic treatment of an anal ailment selected from thegroup consisting of hemorrhoids, anal fissures, and pruritis ani; and anapplicator portion defining one or more apertures, the applicatorportion having a length of approximately 4.5 to 5.0 cm, the applicatorportion comprising a first end adjacent to the reservoir portion and alongitudinal portion extending away from the reservoir portion, whereinthe first end is flanged outward from the longitudinal axis of theapplicator portion such that the first end defines an outer diameterthat is substantially greater than any outer diameter along thelongitudinal portion and that is less than the outer diameter of theportion of the reservoir portion adjacent the first end, wherein thedispenser is configured, by squeezing the reservoir portion, fortopically administering the single dosage amount of the pharmaceuticalcomposition onto the surface of an anal target area afflicted by theanal ailment, wherein the squeezing causes a substantial portion of thesingle dosage amount of the pharmaceutical composition to be dispensedthrough the one or more apertures onto the anal target area, and whereinan open end of the reservoir portion is threaded for removable couplingto the applicator portion.
 2. The dispenser of claim 1, wherein an openend of the reservoir portion is threaded for removable coupling to theapplicator portion and for removable coupling to a threaded cap.
 3. Thedispenser of claim 1, wherein the one or more apertures comprises aplurality of apertures, the dispenser configured to dispense thecomposition through the plurality of apertures.
 4. The dispenser ofclaim 1, further comprising a sealed package defining an interior spaceconfigured to accommodate the reservoir portion and the applicatorportion, wherein the package comprises a base approximately 86.25 mmlong and 61.00 mm wide, wherein the sealed package comprises a blisterpack having a child resistant seal, the blister pack defining a bubblethat rises approximately 17.50 mm above a base of the blister pack, andwherein the dispenser is removably contained in the blister pack.
 5. Thedispenser of claim 1, wherein the squeezing applies pressure in adirection not substantially parallel to a longitudinal axis of a tubularportion of the reservoir portion.
 6. The dispenser of claim 1, whereinthe anal target area afflicted by the anal ailment comprises an externalarea of an outer region of the anus having less systemic pharmaceuticalreceptivity than an inner region of the anus.
 7. The dispenser of claim1, wherein the applicator portion comprises a first end adjacent to thereservoir portion and a tip opposite the first end, wherein at least oneof the one or more apertures is longitudinally spaced from the tip. 8.The dispenser of claim 7, wherein the at least one aperturelongitudinally spaced from the tip is configured to dispense a portionof the composition, in a direction not substantially parallel to thelongitudinal axis of the applicator, onto the surface of the anal targetarea.
 9. The dispenser of claim 1, wherein the applicator portioncomprises a first end adjacent to the reservoir portion and a tipopposite the first end, wherein one of the one or more apertures islocated on the tip of the applicator portion.
 10. The dispenser of claim1, further comprising a removable cover configured to surround thelongitudinal portion of the applicator portion.
 11. The dispenser ofclaim 10, wherein the applicator portion comprises a circumferential ribconfigured to engage the removable cover.
 12. The dispenser of claim 10,wherein the cover comprises a protrusion configured to removably plugone of the one or more apertures.
 13. The dispenser of claim 11, whereinthe applicator portion comprises a first end adjacent to the reservoirportion and a longitudinal portion, the longitudinal portion extendingaway from the reservoir portion and defining an aperture at a tipopposite the first end, wherein the protrusion is configured toremovably plug the aperture at the tip.
 14. The dispenser of claim 10,wherein the cover is less than approximately 4.0 cm in length.
 15. Thedispenser of claim 10, wherein the cover is approximately 3.5-4.0 cm inlength.
 16. The dispenser of claim 1, wherein the applicator portion isconfigured for removable coupling to the reservoir portion.
 17. A methodfor topically dispensing a single dosage amount of a pharmaceuticalcomposition, comprising: removing a covering from an applicator portionof a disposable dispenser, the dispenser also forming a reservoirportion, the reservoir portion being formed from a material deformableby squeezing, the reservoir portion defining a space containing a singledosage amount of a pharmaceutical composition formulated for the topicaltreatment of an anal ailment selected from the group consisting ofhemorrhoids, anal fissures, and pruritis ani, the pharmaceuticalcomposition comprising lidocaine and hydrocortisone acetate; insertingthe applicator portion into an anal area of an anus, the applicatorportion defining one or more apertures and having a length of less thanapproximately 5.0 cm; topically administering the single dosage amountof the pharmaceutical composition onto the surface of an anal targetarea afflicted by the anal ailment by dispensing a substantial portionof the single dosage amount through one or more apertures defined by anapplicator portion of the dispenser, wherein the dispensing step iscarried out by squeezing the reservoir portion to cause at least thesubstantial portion of the single dosage amount to dispense from the oneor more apertures; and discarding the dispenser after use.
 18. A kit fortopical application of anal medication, the kit comprising: a disposabledispenser comprising: a reservoir portion less than approximately 6.5 cmin length, the reservoir portion defining a space, the reservoir portionformed from a material deformable by squeezing; a single dosage amountof a pharmaceutical composition formulated for the topical treatment ofan anal ailment selected from the group consisting of hemorrhoids, analfissures, and pruritis ani, the single dosage amount substantiallyfilling the space and comprising lidocaine and hydrocortisone acetate;and an applicator portion less than approximately 5.0 cm in lengthcomprising a first end adjacent the reservoir portion and a longitudinalportion defining at least one aperture, the first end being flangedoutward from the longitudinal axis of the applicator portion such thatthe first end defines an outer diameter that is substantially greaterthan any outer diameter of the longitudinal portion and that is lessthan the outer diameter of the portion of the reservoir portion adjacentthe first end, the longitudinal portion being tapered from the first endto an opposite end of the longitudinal portion; a removable coverconfigured to surround the longitudinal portion of the applicatorportion; and a blister pack defining an interior configured toaccommodate the reservoir portion, the applicator portion, and theremovable cover, the blister pack having a child resistant seal, whereinthe dispenser is configured, by squeezing the reservoir portion, fortopically administering the single dosage amount of the pharmaceuticalcomposition onto the surface of an anal target area afflicted by theanal ailment, wherein the squeezing applies pressure in a direction notsubstantially parallel to the longitudinal axis of the reservoir portionand causes a substantial portion of the single dosage amount of thepharmaceutical composition to dispense from the at least one apertureonto the anal target area.